First Stemless Reverse Shoulder Arthroplasty System Receives FDA Clearance in U.S.

Concepts that engage proximal humeral bone near cortical boundaries may avoid diaphyseal stems in appropriately selected patients. Following extensive U.S. evaluation, a new system now offers the first FDA‑cleared stemless reverse shoulder option in the country.

FX Shoulder Solutions (Addison, TX, USA) received U.S. Food and Drug Administration (FDA) 510(k) clearance on November 5, 2026, for Easytech Reversed, which the company identifies as the first stemless reverse shoulder arthroplasty system cleared in the United States. The system introduces a stemless approach to reverse shoulder arthroplasty, offering an alternative to conventional methods of humeral fixation. It is intended for use in appropriately selected patients in accordance with its cleared indications.

At the core of Easytech Reversed is a peripheral fixation concept designed to achieve humeral stability without an intramedullary stem by engaging proximal humeral bone near cortical boundaries. The construct shares the humeral anchor base architecture of the Easytech Stemless Anatomical System, which has been available in the United States since 2021. Streamlined instrumentation uses two trays to support procedural efficiency.

FDA clearance followed a U.S. Investigational Device Exemption clinical investigation initiated in 2018 across seven investigational sites and 90 patients, with study follow‑up completed in 2023. These data supported the system’s development, regulatory evaluation, and eventual 510(k) clearance. The U.S. introduction expands the options available for reverse shoulder reconstruction.

“Easytech Reversed marks an important milestone in the evolution of reverse shoulder arthroplasty and reflects FX’s sustained commitment to meaningful innovation,” said Uma Srikumaran, MD, MBA, MPH, of Columbia, Maryland.

“Easytech Reversed introduces a fundamentally different approach to reverse shoulder reconstruction, offering surgeons a unique fixation option for patients with atypical proximal humeral anatomy or malaligned intramedullary canals, as well as those meeting traditional reverse shoulder arthroplasty indications. Its innovative, unique-to-market peripheral fixation design provides the opportunity to achieve humeral fixation without a conventional intramedullary stem in appropriately selected patients, representing a significant advancement in the options available for shoulder reconstruction,” said Dr. Srikumaran.

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